GDUFA Research Outcomes

BE Methods & Analyses

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to bioequivalence methods and analyses for generic drug products.

• All(237)
• Posters(60)
• Presentations(64)
• Papers(113)

• The Development of In Vivo Predictive Dissolution (Ipd) System, Mini-Gastrointestinal Simulator (Mgis), for Bcs Class Iib Drug. The Case Study of Anticancer Drug; Dasatinib.

  Amidon, Gordon

• Solubility and Dissolution of Binary Co-Amorphous Ritonavir-Lopinavir Solid Dispersions

  Taylor, Lynne

• Dissolution Behavior and Solubility of Marketed Amorphous Solid Dispersions of Tacrolimus

  Taylor, Lynne

• Stability of Marketed Tacrolimus Amorphous Dispersions Against Crystallization

  Taylor, Lynne

• A Stochastic Fluid Packet Emptying and Transit Model: A Physiological Approach to Gastrointestinal Transit of Fluid

  Amidon, G L

• Fasted-State Motility-Dependent Gastric Emptying and Plasma Level Variation: Bioequivalence Implications for BCS Class I Drugs

  Amidon, G L

• Evaluation of the Dissolution Drug Release Profiles of Approved Generic Formulations in Multiple pH Media for Putative Biopharmaceutics Classification System Class III Drugs, Atenolol Tablets and Acyclovir Tablets

  Selaya, Daniela; Hunt, Robert; Ren, Ping; Li, David; Qu, Haiou; Yang, Wen Cheng; Wang, Jiang; Chan, Theresa; Kim, Myong Jin; Faustino, Patrick; Zhang, Yi

• Effect Of Crystallinity On The Bioavailability Of Marketed Tacrolimus Amorphous Solid Dispersions

  Purohit, Hitesh; Osterling, Donald; Jenkins, Gary; Stolarik, DeAnne; Gao, Wenqing; Gao, Yi; Zhang, Geoff; Taylor, Lynne

• Limitation In The Pharmacopeial Dissolution Testing Of Marketed Tacrolimus Amorphous Solid Dispersions

  Purohit, Hitesh; Gao, Yi; Zhang, Geoff; Sun, Dajun; Wen, Hong; Taylor, Lynne

• An R-Shiny Application for Design of Comparative Clinical Endpoint Bioequivalence Studies

  Park, Wansu; Kim, Myongjin; Zhao, Liang; Fang, Lanyan